Placental Passage and Disposition of Drugs: A Physiology-based Approach (PIANO)

Radboud University Medical Center

Status: Enrolling

Conditions: Pregnancy

Study type: Observational

Funder types: Other; NETWORK; Industry

Identifiers

NCT02438631

PIANO

Details and patient eligibility

About

The investigators aim to integrate the outcomes in physiology-based pharmacokinetic (PBPK) models to put the generated data into context with medical conditions that require maternal or fetal drug therapy (e.g. HIV). These models will be validated with available 'real-life' maternal and fetal PK data, such as data from the PANNA network.

PBPK models of drug therapy during pregnancy will provide a powerful tool to 1.) assist in designing rational dosing adjustments, 2.) prevent intervention-based research in pregnant women in the future, and 3.) guide future development of new molecular entities (e.g. preventing heavy investment in drugs with high predicted fetal exposure and potentially toxic effects in utero).

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female
• Age > 18
• Signed informed consent
• >38 weeks pregnant

Exclusion criteria

• Retained placenta
• HIV infected
• Known hepatitis C infection
• Multiple pregnancy
• Congenital birth defects child
• Sectio EXIT procedure